FDA to Review Adynovate Proposed Peds, Surgery Indications

FDA to Review Adynovate Proposed Peds, Surgery Indications

Baxalta announced that it has submitted to the Food and Drug Administration (FDA) supplemental Biologics License Applications (sBLAs) for Adynovate [Antihemophilic Factor (Recombinant), PEGylated] to expand its indications to treat children <12 years old with hemophilia A and for use in surgical settings.

The sBLA submission for the pediatric indication was supported by data from a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Adynovate in children <12 years. Results showed that Adynovate met its primary endpoint. No patients developed inhibitory antibodies to the drug and no treatment-related serious adverse effects were reported. The median overall annualized bleeding rate (ABR) in Adynovate-treated patients was 2 (range 0-49.8; mean ABR 3), comparable to the rates seen in the adult study.

The submission was also supported by positive data from a Phase 3 study evaluating the efficacy and safety of Adynovate for the perioperative control of hemostasis in patients with severe hemophilia A undergoing surgical procedures. Results showed that Adynovate achieved hemostasis control from the beginning of the procedure until discharge or Day 14.

Adynovate is currently indicated for the treatment of hemophilia A in adolescent and adult patients (≥12 years old) for prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding.

Adynovate is an extended circulating half-life recombinant Factor VIII (rFVIII) based on Advate [Antihemophilic Factor (Recombinant)]. It uses a proprietary PEGylation technology designed to extend the amount of FVIII available in the body by maintaining the integrity of the parent molecule (Advate) and reducing the time of its clearance, resulting in increased circulating half-life.